1.Effect of Kidney-reinforcing, Blood-activating and Phlegm-resolving Therapy on Left Ventricular Fibrosis of Spontaneously Hypertensive Rats
Qiong WANG ; Shaoxiang XIAN ; Zhongqi YANG ; Bingqing LYU ; Zheng ZHOU ; Jiao DUAN ; Yaqin TANG
Journal of Guangzhou University of Traditional Chinese Medicine 2017;34(3):397-400
Objective To explore the therapeutic mechanism of kidney-reinforcing,blood-activating and phlegmresolving therapy for left ventricular fibrosis of spontaneously hypertensive rats (SHR).Methods Twenty SHR were randomly assigned to Chinese medicine group and model group.Additionally,ten Wistar-Kyoto(WKY) rats served as normal control group.After 12-week prevention,Masson staining method was used to measure the degree of fibrosis of left ventricular myocardial tissues,reverse transcription-polymerase chain reaction(RT-PCR) was used to detect Smad3 mRNA expression,and Western blotting method was used for the detection of Smad3 protein expression.Results The degree of left ventricular fibrosis myocardial tissue in Chinese medicine group was milder than that in the model group,and Samd3 protein and mRNA expression levels in Chinese medicine group were lower than those in the model group (P < 0.05).Conclusion Kidney-reinforcing,blood-activating and phlegmresolving therapy can improve left ventricular fibrosis in SHR by inhibiting Smad3 expression.
2.Evaluation of clinical application of salvianolate for injection
Qinqin ZHAO ; Lisong LYU ; Yanhua CHEN ; Chengle LI ; Bingqing LIANG ; Wenjuan YANG
Chinese Journal of Primary Medicine and Pharmacy 2020;27(10):1198-1202
Objective:To investigate the clinical application of salvianolate for injection in Tongde Hospital of Zhejiang Province and evaluate its rationality of injection.Methods:From March 2018 to November 2018, 560 patients treated with salvianolate for injection in Tongde Hospital of Zhejiang Province were selected by random sampling method.The indications, usage and dosage, route of administration, choice of vehicle, concentration of vehicle, course of treatment, compatibility, contraindications and adverse reactions of salvianolate for injection were analyzed retrospectively.Results:Totally 560 inpatients received salvianolate for injection were collected, about 26.96%(151/560) was consistent with the indication, 99.82%(559/560) with a correct administration dosage and frequency, 100.00%(560/560) with right administration route, 95.00%(532/560) with a right solvent selection, 67.86%(380/560) with correct solvent concentration, 61.07%(342/560) with a correct treatment course, 100.00%(560/560) with a right medicine combination, about 94.46%(529/560) was consistent with coagulation function contraindication, about 90.18%(505/560) was consistent with liver function contraindication.The incidence of adverse reactions was 1.61%(9/560).Conclusion:In the clinical application of salvianolate for injection, a high rate of unreasonable usage is found in indication, treatment course and solvent selection.Because of the serious problems in the use of salvianolate injection, it should be used strictly to ensure clinical medication safety.
3.Optimization of Adaptive Design in Clinical Research and Inspiration for Traditional Chinese Medicine Research and Development
Ruiting LYU ; Bingqing LU ; Wenyuan LI ; Jianyuan TANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):110-119
In recent years, adaptive design has gradually emerged in clinical trials, gaining widespread application and expansion. Compared with traditional randomized controlled trials, appropriate adaptive design can save time and resources to some extent, improve the validity of the trial results and strength of the evidence, align better with ethical requirements, and facilitate subsequent drug market research. However, due to the greater flexibility of adaptive design, controlling type Ⅰ error rates and truly enhancing research efficiency are challenging aspects of its application. Therefore, the normative application and optimization of adaptive design in research deserve early focus, including adhering to good adaptive design principles, conducting rigorous pre-design planning, scientifically applying various statistical methods such as Bayesian dynamic models and simulation methods, and utilizing monitoring tools like monitoring committees to ensure the scientific integrity of the research process. Moreover, the flexibility of adaptive design aligns well with the practical realities of traditional Chinese medicine (TCM) clinical practice. The main characteristics of TCM, such as the holistic concept and treatment based on syndrome differentiation, determine that TCM provides a dynamic and personalized treatment plan. In contrast, the traditional fixed development approach of western medicine limits the application of "human experience" in TCM. To address this bottleneck in TCM research and development, the innovative use of adaptive design, a modern scientific theory and methodology with multiplicity and variability, offers a feasible new approach for TCM clinical research and the innovation of Chinese herbal medicine. By learning from successful cases such as the first Food and Drug Administration (FDA)-approved oral botanical drug, Crofelemer, researchers can explore optimal solutions for adaptive design in clinical research protocols and its role in the "three-combination" evaluation system for Chinese herbal medicines, further refine trial design, clarify key trial points, and develop innovative research and development applications that adapt to the clinical positioning of TCM and highlight the characteristics and advantages of TCM, paving the way for the clinical efficacy, pharmacological mechanism exploration, and post-market efficacy evaluation of Chinese herbal compounds.